Evaluation of Gynecological Acceptability of 3 Health Care Products

Herbarium Laboratorio Botanico Ltda65 enrolled

Overview

The research was conduct with 3 different products for use in the intimate region in up to 70 research participants, that use the investigational product by 35 ± 2 days. The subjects were follow up throughout the study by a gynecologist for verification of safety, effectiveness and possible adverse events.

At this study, 70 female participants, 18 to 70 years, healthy with complaints of vaginal dryness used the 3 investigational product, each one by 9 days. Between the changes of product use, there were 4 days of wash out. At the 9th day, the participants answered assessment questionnaire.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Atrophic Vaginitis Vaginal Disease

Interventions

Hyaluronic acid - Research product 1OTHER

Health care product (intimate gel)

Hyaluronic acid - Research product 2OTHER

Health care product (intimate gel)

Hyaluronic acid - Comparator productOTHER

Health care product (intimate gel)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Health volunteers * Non-injured mucosa in the test region; * Agreement to adhere to study procedures and requirements and attend the institute on the day(s) and time(s) determined for the evaluations; * Ability to consent to their participation in the study; * Age from 18 to 70 years old; * Female participants; * Vaginal dryness (slight minimum) - according to questions from the gynecologist. Exclusion Criteria: * Pregnancy or breastfeeding; * Skin pathology in the area of application of the product; * Diabetes Mellitus type 1; insulin-dependent diabetes; presence of complications due to diabetes (retinopathy, nephropathy, neuropathy); presence of diabetes-related dermatoses (plantar ulcer, lipoid necrobiosis, annular granuloma, opportunistic infections); history of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma; * Current use of the following medications for topical or systemic use: corticosteroids, immunosuppressants and antihistamines; * Skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis; * History of reaction to the category of the tested product; * Other diseases or medications that may directly interfere with the study or endanger the health of the research participant.

Locations (1)

Allergisa Pesquisa Dermato-Cosmética Ltda

Campinas, Brazil

Outcomes

Primary Outcomes

Perceived hydration

Evaluate the perceived hydration, through a subjective questionnaire based on "Standard Guide for Sensory Claim Substantiation"

Time frame: 9 days

Data from ClinicalTrials.gov

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